Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000819
Status:
COMPLETED
Last Update Posted:
2021-10-29
First Post:
1999-11-02
Brief Title:
A Phase II Randomized Double-Blind Placebo-Controlled Trial to Determine the Efficacy of Prednisone Therapy in HIV-Associated Nephropathy HIVAN
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase II Randomized Double-Blind Placebo-Controlled Trial to Determine the Efficacy of Prednisone Therapy in HIV-Associated Nephropathy HIVAN
Status:
COMPLETED
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To determine the efficacy and safety of prednisone in patients with HIV-associated nephropathy To determine the effects of prednisone on serum creatinine urinary protein and creatinine clearance
HIV-associated nephropathy is characterized by heavy proteinuria rapidly progressive renal insufficiency and distinct nephropathologic changes The syndrome most often occurs in patients with advanced HIV disease Little is known about the effects of corticosteroids on the progression of HIV disease In light of the possible beneficial effects of corticosteroids on HIV-associated nephropathy a controlled trial using prednisone is warranted
HIV-associated nephropathy is characterized by heavy proteinuria rapidly progressive renal insufficiency and distinct nephropathologic changes The syndrome most often occurs in patients with advanced HIV disease Little is known about the effects of corticosteroids on the progression of HIV disease In light of the possible beneficial effects of corticosteroids on HIV-associated nephropathy a controlled trial using prednisone is warranted
Detailed Description:
HIV-associated nephropathy is characterized by heavy proteinuria rapidly progressive renal insufficiency and distinct nephropathologic changes The syndrome most often occurs in patients with advanced HIV disease Little is known about the effects of corticosteroids on the progression of HIV disease In light of the possible beneficial effects of corticosteroids on HIV-associated nephropathy a controlled trial using prednisone is warranted
Patients are randomized to receive prednisone or placebo for 11 weeks followed by 13 weeks of observation
Patients are randomized to receive prednisone or placebo for 11 weeks followed by 13 weeks of observation
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 11247 | REGISTRY | DAIDS ES Registry Number | None |